BEUDAMED
    FDA Recall Terminated

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    Recall: Z-0441-2013 · Initiated November 13, 2012

    Recall

    Recall Number
    Z-0441-2013
    Event Number
    63722
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 13, 2012
    Posted
    November 29, 2012
    Terminated
    January 4, 2013
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    Reason

    Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.

    Action

    Medtronic Navigation sent a Urgent Medical Device Recall letter dated November 13 -14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed do not use the Vertex Max Cannulated Drill Tube clinically. Medtronic Navigation will remove the Vertex Max Cannulated Drill Tube. Medtronic Navigation will provide a replacement Vertex.Max Cannulated Drill Tube manufactured from a different lot which was inspected to verify the defect has been corrected. If you have any questions about this notification, please contact a Sales Representative in your area. For further questions please call (720) 890-3200 Ext. 3303 .

    Distribution

    Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.

    Quantity

    12 Units